COVID-19 IgM/IgG rapid diagnostic test A006019 (50 kits)

The COVID-19 lgG/lgM (Blood/Serum/Plasma) Rapid Diagnostic Test is a rapid-phase immunochromatographic test for the rapid, qualitative, and differential detection of lgG and lgM antibodies against the novel coronavirus 2019 in human whole blood, serum, or plasma. Exclusive use by qualified and properly trained professionals.

The expiry date of these tests is 03/12/2020.

IMPORTANT NOTE: According to notification from the AEMPS, RD 21/2020 has been published, which annuls the Ministerial Orders that were approved under the state of alarm, including Order SND/344/2020, of 13 April. Consequently, a medical prescription is no longer required for the sale of this product.

BOX OF 50 TESTS Includes:
50 Rapid Tests (Cassette + 2 Buffer)
50 Safety Lancets
50 Antiseptic Wipes50 Antiseptic Wipes
1 Jar
1 Instructions for use and leaflet

CHARACTERISTICS

This test only provides a preliminary test result. Therefore, any sample reactive with the COVID-19 IgG/IgM (Whole Blood/Serum/Plasma) Rapid Test Cassette should be confirmed with alternative testing methods and clinical findings.

INSTRUCTIONAL VIDEO

WARNINGS & PRECAUTIONS

1. The test is for single use only. It should not be reused under any circumstances.
2. For professional in vitro diagnostic use only. Do not use after expiry date.
3. Read the instructions for use before performing the test, so that you do not get inaccurate test results.
4. Handle all specimens as if they contained infectious agents. Observe established precautions against microbiological hazards during testing and follow standard procedures for proper sample disposal.
5. Wear protective clothing such as lab coats, disposable gloves, and eye protection when samples are tested.
6. Humidity and temperature can negatively affect results.
7. Do not test in a room with strong airflow, i.e., electric fan or strong air conditioning.

PRINCIPLES & COMPONENTS

The COVID-19 IgG/IgM (Whole Blood/Serum/Plasma) Rapid Test Cassette is a lateral flow immunochromatographic assay. The test uses anti-human IgM antibodies (IgM test line), anti-human IgG (IgG test line), and anti-goat rabbit IgG (C control line) immobilized on a nitrocellulose strip.

The burgundy conjugated pad contains colloidal gold conjugated with recombinant COVID-19 antigens conjugated with colloidal gold (COVID-19 conjugates) and IgG-rabbit gold conjugates.

When a specimen followed by assay buffer is added to the sample well, IgM and/or IgG antibodies, if present, will bind to COVID-19 conjugates making antigenic antibodies complex. This complex migrates across the nitrocellulose membrane by capillary action.

When the complex meets the line of the corresponding immobilized antibody (anti-human IgM and/or anti-human IgG), the complex is trapped forming a burgundy band confirming a reactive test result. The absence of a colored band in the test region indicates a non-reactive test result.

To serve as a procedural control, a colored line will always change from blue to red in the control line region, indicating that the appropriate volume of sample has been added and membrane absorption has occurred.

MATERIAL SUPPLIED

• 50 sealed bags, each containing a test cassette, dropper, and desiccant
• 1 tampon
• 1 x Instructions for Use

MATERIAL REQUIRED BUT NOT SUPPLIED

• Sample Collection Containers
• Lancets (for whole blood with fingerstick only)
• Centrifuge (plasma only).
• Timer
• Heparinized capillary tubes and dispenser bulb (whole blood fingerstick only)

STORAGE CONDITIONS

The kit can be stored at room temperature or refrigerated (2-30°C). The test device is stable until the expiration date printed on the sealed bag. The test device should remain in the sealed bag until use. Do not freeze. Do not use beyond the expiration date.

SAMPLING AND PREPARATION

1. The COVID-19 IgG/IgM (Whole Blood/Serum/Plasma) Rapid Test Cassette can be performed using whole blood, serum, or plasma.

2. Separate serum or plasma from blood as soon as possible to avoid hemolysis. Use only clear, non-hemolyzed samples.

3. Testing should be performed immediately after sample collection. Do not leave samples at room temperature for long periods of time. Serum and plasma samples can be stored at 2-8°C for up to 3 days. For long-term storage, samples should be kept below -20°C. Whole blood collected by venipuncture should be stored at 2-8°C if the test will be performed within 2 days of collection. Do not freeze whole blood samples. Whole blood collected by fingerstick should be tested immediately.

4. Bring samples to room temperature before testing. Frozen specimens should be thawed completely and mixed well before testing. Samples cannot be frozen and thawed repeatedly.

5. If specimens are to be shipped, they must be packaged in accordance with local regulations covering the transportation of etiologic agents.

OUTLINE OF THE VISUAL PROCEDURE

Allow the test cassette, sample, buffer, and/or controls to be balanced at room temperature (15-30°C) prior to testing.

1. Remove the test cassette from the sealed foil pouch and use it as soon as possible. Better results will be obtained if the trial is performed within an hour.

2. Place the test device on a clean, level surface.
For Serum or Plasma Samples:
Using a provided 5μL mini plastic dropper, draw a serum/plasma sample to exceed the sample line as shown in the image below and then transfer the sample drawn from serum/plasma to the sample well (S). Then add 2 drops (about 80μL) of sample buffer to the buffer well (B) immediately. Avoid air bubbles.

Note: Practice a few times before the test if you are not familiar with the mini dropper. For best accuracy, transfer the sample with a pipette capable of delivering 5 μL of volume.

For Whole Blood Samples:
Hold the 5 μL mini plastic dropper vertically and transfer 1 drop of whole blood (about 10 μL) to the sample well (S) of the test device, then add 2 drops (about 80 μL) of sample buffer to the buffer well (B) immediately. Avoid air bubbles.

3. Wait for the colored lines to appear. After 2 minutes, if the red color has not moved through the test window or if there is still blood in the sample well (S), add an additional 1 drop of the sample buffer to the buffer well (B).

4. The result should be read within 10 minutes. Positive results may be visible as early as 2 minutes. Do not interpret the result after 15 minutes.

INTERPRETATION OF RESULTS

NEGATIVE: The color line in the control line region (C) changes from blue to red. No line appears in test line regions M or G. The result is negative.

IgM POSITIVE: The colored line in the control line region (C) changes from blue to red, and a colored line appears in the test line region M. The result is anti-COVID-19 IgM positive.

IgG POSITIVE: The colored line in the control line region (C) changes from blue to red, and a colored line appears in the G test line region. The result is anti-COVID-19 IgG positive.

IgG and IgM POSITIVE: The color line in the control line region (C) changes from blue to red, and two colored lines appear in the test line regions M and G. The result is anti-COVID-19 IgM and IgG positive.

DISABLED: The control line is still completely or partially blue and cannot change completely from blue to red. Insufficient sample volume or incorrect procedure techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test tape. If the problem persists, stop using the test kit immediately and contact your local distributor.

QUALITY CONTROL

A procedural check is included in the test. A red line appearing in the control region (C) is the internal procedure control. Confirm sufficient sample volume and correct procedure technique. Control standards are not supplied with this kit; however, it is recommended that positive and negative controls be tested as good laboratory practice to confirm the test procedure and verify proper test performance.

LIMITATIONS OF THE PROCEDURE

1. Use fresh samples whenever possible. Frozen and thawed samples (especially repeatedly) contain particles that can block the membrane. This slows down the flow of reagents and can generate a raised background color, which makes it difficult to interpret the results.
2. Optimal test performance requires strict compliance with the test procedure described in this leaflet. Deviations can lead to aberrant results.
3. A negative result for an individual subject indicates absence of detectable anti-COVID-19 antibodies. However, a negative result does not exclude the possibility of exposure or infection with COVID-19.
4. A negative result may occur if the amount of anti-COVID-19 antibodies present in the sample is below the test detection limits, or if the detected antibodies are not present during the stage of the disease in which a sample is collected.
5. Some samples containing an unusually high titer of heterophile antibodies or rheumatoid factor may affect the expected results.
6. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the result of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.

CLINICAL PERFORMANCE

The COVID-19 IgG/IgM Rapid Test (Whole Blood/Serum/Plasma) has been evaluated with the 113 blood samples obtained from patients with pneumonia or respiratory symptoms. The results were compared with RT-PCR or clinical diagnosis (including Computerized Tomography of the chest and clinical signs, etc.) from "Diagnosis and treatment of novel coronavirus pneumonia".

As for the IgM test, the comparison of results with RT-PCR.

Regarding the IgG test, we counted the positive rate of 36 out of 113 patients during the recovery period

The sensitivity of the IgM test is 87.9% (87/99) and the specificity is 100% (14/14) compared to RTPCR.

The sensitivity of the IgG test is 97.2% (35/36) during the convalescence period, and the specificity is 100% (14/14).

SYMBOLISM

ABOUT SECURITY

Sekureco is a company that emerged in 2016 thanks to the passion of several technicians specialized in prevention and safety at work and due to the lack of companies really specialized in labor protection on the market.